On voluntary and obligatory nanotechnology labelling

(Nanowerk Spotlight) Similar to the earlier debate on genetic engineering,1 there is discussion on specific
labelling for nano-products (see next section
for details). With regard to consumer
products – for example food, cosmetics,
plant protectants, detergents, textiles and
other commodities – labelling obligations
gradually replace and act alongside traditional
legal instruments such as authorisation
procedures. As a result, consumers,
through their purchasing decisions, take part
in risk assessment and management.2

Although labelling requirements are relatively
mild regulatory tools, they may impose
considerable commitments upon the
obligated parties. Nevertheless, EU law increasingly
relies upon labelling to govern
risks in different areas of life.3 The labelling
of nano-products has been a demand at
member state4 and European level5. While
such ambitions in member states – often
with a reference to the European level –
have come to a standstill,4 there are already
explicit European nano-labelling obligations
for cosmetics, food and biocidal
products. The present dossier outlines the
international debate as well as existing voluntary
regimes, analyzes nano-labelling obligations
within EU law and presents unsuccessful
efforts at labelling for electrical
and electronic appliances as well as for
novel foods.

The debate on the labelling of nano-products

Labelling increasingly plays a role in risk
control and technology regulation.6 When
traditional legal instruments reach their limits,
use is made of information instruments,
ranging from product information and recommendations
to warnings.7 In addition
to government and other official authorities,
information is also given by the industry,
which labels its products either voluntarily
or following an obligation.8

With regard to nanotechnology, labelling
has also been called for on numerous occasions.
Back in 2004, The Royal Society
& The Royal Academy of Engineering (UK)
proposed the inclusion of synthetic nanoparticular
materials in the list of components
and/or contents of consumer products.9 On
the one hand, experts argue that chemicals
in the form of nano-particles should be
treated as new substances. On the other
hand, there is a need for transparency and
information.

The Canadian environmental protection organisation
Action Group on Erosion, Technology
and Concentration (ETC-Group)
assesses the risks of synthetic nano-materials
as high and called for a moratorium
as early as 2003.10 In 2006, the organisation
set up a competition to find a “nanohazard
symbol” for labelling products or
transport containers and for installing warning
notices in laboratories and factories.

The winners of the “nano-hazard symbol” competition of the Canadian ETC-group11

A number of countries have held public discussions,
polled citizens or held consumer
conferences on the topic of nanotechnology.
The German Bundesinstitut für Risikobewertung
(BfR) held a consumer poll in 2006.12
The consumer group consisting of 16 citizens
urged producers to list particle size alongside
ingredients for cosmetics, and to label
nano-refined textiles. The Zentrum für Technologiefolgen-
Abschätzung (TA-SWISS) held
what were known as publifocus events on the
topic “Nanotechnologien und ihre Bedeutung
für Gesundheit und Umwelt” (“Nanotechnologies
and their importance for health
and the environment”) throughout Switzerland.
TA-SWISS asked randomly-chosen
citizens if a uniform declaration would be
necessary.13 The discussion events revealed
a huge demand for information. There was
concern amongst the participants that they
had already unknowingly bought products
with synthetically manufactured nano-particles.
The majority called for an obligation
for novel products to be declared. The British
consumer protection organisation Which?
organised a consumer conference at the end
of 2007.14 The participants called for the labelling
of cosmetic products containing loose
nano-particles. To avoid confusion, the participants
demanded better information on
nanotechnology. Which? also carried out a
survey on the issue of “Nanotechnology” in
2008. 67% spoke out in favour of the clear
labelling of cosmetics and personal care
products manufactured on the basis of nanotechnology.

In July 2007, 70 civil-society groups, environmental
associations and labour unions of different
nations presented their “Kriterien zur
Kontrolle von Nanotechnologie und Nanomaterialien”
(“Criteria for the control of nanotechnology
and nano-materials”).15 The
signatories emphasised that specific instruments
were necessary in order to evaluate
and control nano-materials. This included
labelling consumer products containing nano-
materials, information rights and safeguards
at the workplace as well as an openly
accessible database on health and security
information.

In Austria, Ärztinnen und Ärzte für eine gesunde
Umwelt, die Umweltberatung, the
Österreichische Ökologie-Institut and the
Verein für Konsumenteninformation (VKI)
published a position paper in December
2007, which called amongst other things for
general and easily comprehensible information
on nano-products.16 The packaging
should provide information on nano-materials
for consumers and advisory organisations.

The two European consumer protection organisations
– The European Consumers’
Organisation (BEUC) and The European
Consumer Voice in Standardisation (ANEC)
– also advocate greater transparency and
labelling of consumer products containing
nano-materials.17 In addition, the Öko-Institut
e.V. (Freiburg, Germany) demands that
consumers be allowed to freely choose if they
wish to buy products for which it cannot be
ruled out that they contain loose nano-particles
(e.g. foods, cosmetics, detergents and
care products). A labelling obligation could
substantially increase transparency.18

The Bund für Umwelt und Naturschutz
Deutschland e.V. (BUND) believes that a labelling
obligation for foods, cosmetics, textiles
and detergents is necessary. Since many
consumers have little understanding of the
term “nanotechnology”, producers would
have to provide further information about the
materials used.19 Greenpeace Österreich
demands labelling on the market to enable
consumers to make well-informed purchase
decisions.20

The industry on the other hand has reservations
against a “nano-label”, arguing that
under certain circumstances it might cause
uncertainty amongst consumers and trigger
(possibly unfounded) anxieties. A simple “nano-
label” could be understood as a warning
symbol, while a label with extensive information,
on the other hand, could lead to
“over-information” and thereby also fail to
meet its purpose.21

The Verband der deutschen Lack- und
Druckfarbenindustrie e.V. has commented
that a specific nano-label would cause a substantial
shift in the EU philosophy of only
highlighting dangerous materials and compositions.22 As nano-particles are not in principle
dangerous by their nature, undifferentiated
labelling could stigmatise and malign
nano-materials in general. This would counteract
opportunities in nanotechnology, such
as to reduce the burden on the environment.
For this reason, the German coating and
printing ink industry speaks out against general
nano-labelling. However, voluntary labelling
for certain coatings and paints – in
connection with the long-established voluntary
product declaration – would be worth
discussing.

Initiatives on voluntary labelling

“Nano” has been readily used as a saleseffective
catchword in the last few years, presumably
also for conventional products that
have nothing to do with nanotechnology. This
is not only unsatisfactory for consumers but
also for the producers; after all, they invest
a large amount of research and development
work in their products. This is the reason
for isolated initiatives in different countries
for voluntary labelling with special labels
and so-called quality seals, which have
failed to succeed on the market, however.23

One example is the forumnano-Gütesiegel
– an initiative by medium-sized German companies
based in Frankfurt/Main launched in
January 2008.24 Since 2008, the quality seal
has only been given to two products, one of
which has already been withdrawn from the
market.

The Hohenstein Institute in Bönnigheim,
Germany, examines textiles containing nanomaterials
with regard to whether their functionality
relies upon nanotechnology, if the
nano-coating is suitable for use and if there
are possible biological risks.25 Four companies’
products have so far received such a
quality label.26

The Institut für Textil- und Verfahrenstechnik
(ITV) in Denkendorf (Germany) together
with the trademark owner Prof. Barthlott
have developed a quality seal for self-cleaning
textiles (e.g. awning fabrics)27:28 “Selfcleaning
inspired by nature”. The test
procedure includes whether superhydrophobia
occurs, whether the material is durable
and whether the surface structures at issue
are present. Information on which companies’
products have so far received the label
is not available.

The British Standards Institution (BSI) published
an instruction for the (voluntary) labelling
of synthetic nano-particles and of products
that contain such particles in 2007.30

The introduction of this new technology on
the market should be open and transparent.
The BSI recommends different labelling for
consumer products, nanoparticles for professional
application and for use on the
wholesale market. The instruction includes
examples of the relevant text information.
These proposals have not been taken up by
the industry.

So far there is no “negative labelling” in the
form of special “nano free”-labels, although
there are sporadic attempts at informing consumers
of products that do not contain artificial
nano-particles. For example, for the
season 2011/2012 the Australian environmental
protection organisation “Friends of
the Earth” published a list of sunscreen products
which are claimed not to contain any
synthetic nano-particles (such as the nanoparticular
UV-filters titanium dioxide and zinc
oxide) according to the manufacturer’s specifications.31 Tests showed, however, that these
indications were not always reliable and that
allegedly “nano free”-sunscreen products did
indeed prove to contain nano-materials.
Consequently, the organisation had to withdraw
the list.32

The British Soil Association was the first organic
farming association which banned its
members from using nano-materials. Since
1.1.2008, products certified by the organisation
– in particular health, cosmetic and
food products as well as textiles – must no
longer contain synthetic nano-materials.33
The German Öko-Verband Naturland criticised
the fact that consumers currently cannot
know if nano-technology is used during
manufacturing, and wants to forbid nanoparticles
in Naturland-certified foods (including
their packaging) by 2012.34

Nano-relevant labelling-obligations in EU-law

Labelling obligations follow different goals:
unambiguous information that will allow
consumers to make responsible purchasing
choices,35 and secure, healthy and sustainable
product development. Such obligations
should also reconcile the diverging interests
of consumers and industry.36 Labelling impacts
depend largely upon what people associate
with different products or technologies.37 Positive or negative associations will
either increase or decrease the purchasing
of nano-products. Informed and responsible
purchasing decisions and secure und healthy
product development require a transparent
legal framework and uniform labelling obligations.38 In any case, labelling obligations
create knowledge. They include those affected
– whether industry or consumers – in risk
regulation.39 In some cases it even replaces
governmental risk management (for example
authorisation procedures).40

While as yet there are no labelling obligations
for nano-products at national level,4
the situation is different at EU level.

Cosmetics

The new European Cosmetics Regulation
came into force on 1.1.2010.41 It also includes
nano-specific provisions.42 As an EU
regulation the provisions are directly applicable
in all member states. Apart from specific
safety assessments and notification obligations,43 it also provides for nano-specific
labelling requirements44. Substances that
correspond with the nano-definition (see below)
are to be included in the list of ingredients
and the word “nano” to be put in brackets.
This is usually included on the product
label, although exceptions are possible in
cases where this is justified. To provide for
a uniform labelling, the EU is creating a glossary
of common ingredient names, which also
includes nano-materials.45 The labelling
of nano-materials is to follow the name used
within the glossary; should no uniform name
be available yet, a generally accepted nomenclature
is to be used.46 As only labelled
cosmetics are considered safe,47 nano-products
may only be marketed provided that
they are specified as such. The labelling requirements
shall apply from 11.7.2013.48
From this date on, all nano-materials used
in production are to be included in the list
of ingredients.

The manufacturer or the importer of the cosmetics
is responsible for the labelling; where
the manufacturer is located outside the EU,
a responsible person must be designated
who shall provide for the proper labelling.49
Additionally, the distributor in question needs
to verify the labelling information before placing
the product on the market.50 The authorities
of the member states are responsible
for monitoring compliance.51 Who these may
be depends upon national legislation. In any
case, the member states shall provide authorities
with proper resources. In Austria, the
provincial governors as well as bodies acting
under their authority are currently primarily
responsible for the control of and
compliance with provisions regarding cosmetics
within the scope of application of the
LMSVG.52

Incorrect labelling may lead to a variety of
consequences: Conditions may be imposed
upon the person responsible for labelling
(manufacturer or importer). The person may
be required to withdraw or recall incorrectly
labelled cosmetics from the market; in any
case, the measures need to be based on the
risk53 and must be justified.54 Depending on
the risk situation the intervention may be undertaken
by carrying out a procedure (and
through an individual administrative decision)
or without procedure (through direct orders
and execute coercive measures). (Administrative)
penalties against the manufacturers
or importers shall be determined by
the member states; these must be “effective,
proportionate and dissuasive”.55

Foods

On 25.10.2011, following several years of
negotiations,56 the EU decided upon the new
provision of food information to consumers57
containing labelling requirements for nanomaterials58
(for definition see below). Like
the Cosmetics Regulation, the Food Information
to Consumers Regulation is directly applicable
in all member states. In general its
aims are to inform consumers and enable
informed purchasing decisions.59 The regulation
contains far reaching labelling requirements
for food, the list of mandatory particulars
is long.60 Labelling is to be effected
in words and numbers, and pictograms and
symbols may be used in addition; the information
is to be written in a language which
is easily comprehensible for the consumer.61

Concretely, there exists a labelling requirement
for ingredients containing nano-materials.
The word “nano” is to be put in brackets
next to the nano-material in question. The
labelling requirements address food business
operators across the entire food chain.62 The
food business operators or the importers are
responsible for proper labelling.63 According
to the Feed and Food Control Regulation,64
the control and surveillance of the obligations
arising from the Food Information to Consumers
Regulation lies with the member states
as well as enacting potential sanctions (Art. 55
of the Feed and Food Control Regulation).

The Food Information to Consumers Regulation
has been in force since 12.12.2011
and will be applicable from 13.12.2014 onwards.
However, the Regulation contains various
transitional provisions: For example,
foods placed on the market and labelled before
13.12.2014 may continue to be marketed.65 This measure aims in particular at
not placing a disproportionate burden upon
food operators.

Biocidal products

On 19.1.2012, following agreement with the
Council,66 the European Parliament, through
ordinary legislative procedure, adopted on
second reading a Regulation on the Making
Available on the Market and Use of Biocidal
Products (Biocidal Product Regulation);67
the decision in the Council of Environmental
Ministers is considered to be a mere formality.68 Generally, the regulation shall apply
from 1.9.2013.69 Possible transitional
provisions (for example for products which
are already on the market) still depend upon
the date of the actual decision.70

The regulation also contains extensive nanospecific
rules. In particular, nano-materials
must undergo a specific risk assessment;71
products containing nano-materials may not
be marketed under a simplified authorisation
procedure;72 member states are required
to report on nano-materials that are on the
market and their potential risks every five
years.73 Finally, the regulation contains extensive
labelling requirements for biocidal
products as well as for treated articles.74

According to the Biocidal Product Regulation,
in addition to other information, there must
be a notice if a product contains nano-materials75
(on the definition see below). Again,
this is to be done by putting the word “nano”
in brackets next to the material; additionally,
specific related risks must be mentioned.
For treated articles containing nano-materials,
these are also to be indicated by the
person that places the treated article on the
market.76 Generally, authorisation holders
are responsible for proper labelling.77

The member states monitor the labelling.78
Under current law, biocidal products are monitored
by the provincial governors, which is
also the case for directly applicable EU law,79
and hence also the labelling requirements
of the future Biocidal Product Regulation.
Concerning the monitoring of proper labelling
of biocidal products, Austrian Biocidal
Product Law80 provides that the provincial
governors concerned issue an annual plan
for monitoring, inter alia, the proper labelling
of biocidal products. Member states are also
responsible for sanctions with regard to
possible violations of the regulations; as in
the Cosmetics Regulation, sanctions should
be “effective, proportionate and dissuasive”.81

Different nano-definitions

The three EU regulations portrayed above
contain different definitions of nano-materials.
At first sight this appears justified, considering
that different nano-materials require
different treatment. However, excessive divergences
in the various legal materials are
harmful for legal unity. This is one of the reasons
why the European Commission issued
a non-binding recommendation containing
a working definition for nano-materials in
October 2011.82 Although the recommendation
itself takes as a premise that existing
provisions are to be left untouched, the Commission
is required to consult its own recommendations
when drafting new regulations
or revising existing legislation.

Within the scope of the Cosmetics Regulation,
which came into force prior to the recommendation,
“nano” “means an insoluble
or biopersistant and intentionally manufactured
material with one or more external dimensions,
or an internal structure, on the
scale from 1 to 100 nm”. What is striking in
this definition is that it focuses exclusively on
the spatial dimension of the materials and
not properties inherent in nano-materials,
for example. The scale also seems quite rigid
as it excludes anything smaller than 1 or larger
than 100 nm. Furthermore, the definition
only encompasses intentionally created nanomaterial.83

The Food Information to Consumers Regulation
also only includes intentionally made
nano-materials. Extraordinarily enough, this
definition does not follow the recommendation
for the definition of nano-materials
made by the Commission84 although they
were issued simultaneously. It departs significantly
from the definition given in the Cosmetics
Regulation: the size restriction is only
limited upwards and even there irregularities
are possible (in cases in which “characteristics
of the nanoscale” appear in structures
larger than 100 nm). In this way, the
EU has responded to criticism regarding the
cosmetics law that a strict 1-100 nm delimitation
is not an appropriate criterion.85 By
including larger structures such as agglomerates
and aggregates, the definition is also
a reaction to the fact that, apart from size,
specific properties are relevant. However, it
retains “properties that are characteristic of
the nanoscale”. These include “i) those related
to the large specific surface area of the
materials considered; and/or ii) specific physico-
chemical properties that are different
from those of the non-nanoform of the same
material”.

Unlike the definition in the Cosmetics Regulation
and the Food Information to Consumers
Regulation, the definition of nanomaterial
in the Biocidal Product Regulation
follows that proposed by the Commission in
its recommendation.84 According to this, nano-
material is a natural or manufactured active
or non-active agent “containing particles,
in an unbound state or as an aggregate or
as an agglomerate and where, for 50% or
more of the particles in the number size distribution,
one or more external dimensions
is in the size range 1 nm-100 nm. Fullerenes,
graphene flakes and single wall carbon nanotubes
with one or more external dimensions
below 1nm should be considered as
nano-materials”. A particle is considered to
be “a minute piece of matter with defined
physical boundaries”; agglomerates are “a
collection of weakly bound particles or aggregates
where the resulting external surface
area is similar to the sum of the surface areas
of the individual components” and an
aggregate “a particle comprising of strongly
bound or fused particles”.

Failed labelling efforts at EU level

For the time being, nano-specific labelling
requirements for electrical and electronic devices
as well as for novel foods have failed.
The European Parliament’s Environment
Committee called for the labelling of all electrical
and electronic devices that contain
nano-materials when revising the Directive
on the Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic
Equipment (RoHS)86, 87 However, – following
massive opposition88 – the revised directive
does not contain any such labelling requirements.89

The efforts in the field of novel foods had
already been more advanced. In 2008, the
Commission proposed a Novel Food Regulation.90 In the course of revision efforts, the
Parliament consequently advocated for a systematic
labelling requirement for novel foods.
The Commission and the Council, on the
other hand, argued in favour of demandbased
labelling.91 The labelling of food
packaging was also discussed, the Council
always presenting the view that this should
be regulated within the framework of the
Food Packaging Regulation. Irrespective of
the different lines of discussion, the revision
finally failed in 2011.

Conclusions

For several years now, environmental and consumer protection organisations in particular
have called for the labelling of “nano-products” to enable consumers to make informed
purchasing decisions. While voluntary initiatives can be regarded as having failed due to
opposition from industry – and probably also a lack of demand from the consumers up until
now – the coming years will see labelling requirements for certain product groups through
provisions of EU law.

Within the EU, a model for labelling has been established; the provisions in question hardly
differ from each other. Accordingly, nano-substances need to be labelled and the word
“nano” added in brackets. An obligation to indicate possible risks is so far only intended
for biocidal products. There are, however, differences as to what nano-materials are. Although
legal uncertainties exist, this seems justified or even necessary considering the fact
that there are strong divergences in application. Within the separate legal materials, the
power of definition is delegated to the administration (the Commission, so to speak), but
not in all aspects. The legislator obviously wants to keep the question of what constitutes a
nano-material within the field of legislation, given that the question is not just technically
but also politically relevant. Industry is responsible for proper labelling. Depending upon
law and subject matter, the persons who primarily bear responsibility vary. Control, monitoring
and sanctions are, however, within the competence of the member states.

Due to the relatively high effort involved in labelling, the obligations are indeed controversial.
The industry needs to comply with them alongside extensive product information for
security assessments and possible registration requirements. Additionally, only evidently risky
products originally needed to be labelled within the EU framework and this labelling should
to some extent have replaced governmental risk assessment. If now only a few product groups
are generally labelled irrespective of whether a certain material or product proves to be a
risk, whether it has undergone risk assessment or has even been subject to an authorisation
procedure, this leads to unequal treatment of different material and product groups.
Furthermore, it would have the unwelcome effect of making risk regulation opaque, thus
possibly leading to systemic weakness. What the effects of labelling are depends largely
upon the renown of certain technologies within society.

91 On this see extensively with further references Eisenberger (Endnote 37) 23.

By NanoTrust, Austrian Academy of Sciences. NanoTrust Dossiers are published irregularly and contain the research results of the Institute of Technology Assessment in the framework of its research project NanoTrust. The Dossiers are made available to the public exclusively on epub.oeaw.ac.at/ita/nanotrust-dossiers.